Atherosclerosis ObliteransSTELLASUPERANCT03020290
Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents
An observational study of Atherosclerosis Obliterans, run by Nantes University Hospital at 2 sites in France.
Trial summary
Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis Obliterans
- What is being tested?
- Endovascular treatment for PAD during medical care (SuperA stent (Abbott))
- Type of treatment
- Medical device
- How many people
- 335 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2016to 10 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients included in this study are major patients and have lower limb arteriopathy requiring a therapeutic gesture in the femoro-popliteal segment. The inclusion in this study will be proposed to the patients during the consultation of preoperative vascular surgery or during the hospitalization, until the day after their intervention. The number of subjects planned is 50. In the case where the patient has bilateral femoropopliteal lesions, the limbs being treated in separate hospitalizations, both members may be treated with SuperA stents. The two members will then be considered independently of each other. Patients with associated lesions requiring treatment, any artery confused, may be treated at the same operative time if deemed necessary by the surgeon.
Who may be able to join
- Age > 18 years,
- Symptomatic PAD, Rutherford 2 to 6
- Atherosclerotic femoropopliteal lesion TASC C or D (on CT scan or arteriography)
- De novo femoropopliteal lesion
- Patient informed of the study and oral authorization collected
Who cannot join
- Under-age patient
- Patient of age, but under legal guardianship or care
- Potentially pregnant women
- Patients do not understand the French language
- Asymptomatic lesion
- Acute ischemia or acute thrombosis
Show all 16Show fewer
- Lesion already treated
- No-atherosclerotic disease
- hemostasis disorder
- severe comorbidity with life expectancy less than 2 years
- contraindication of antiplatelet (dual antiplatelet therapy required during at least 2 month post-intervention)
- patient participating in a clinical trial likely to interfer
- Comorbidity or other, according investigator, that may interferer with the conduct of the study
- lesion near to an aneurysm
- Patient follow-up impossible
- Patient refuse to participate
Trial locations and contacts
2 sites in 1 country.
About this study
Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D).
The primary objective of the study was to evaluate the clinical efficacy at 12 months of the SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D in patients with symptomatic peripheral arterial disease. The secondary objectives are to evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical, morphological and haemodynamic criteria, the possible influence of calcifications and the quality of life of patients.
The SuperA stent treatment is not specifically provided for by the Protocol but is carried out within the framework of the care. This study is an observationnal study.
Read the detailed description
Patient will be recruiting during 1 year. Patient will be followed in the study during 2 years. Pre-operative exams are collected. Patients are asked to give their oral authorization to participate in the study by their surgeon.
Patient can be included up to the next day of the intervention.
Endovascular treatment of femoropopliteal lesion with SuperA stents during medical care:
Intervention will be achieved in operative room, under local anesthesia and sedation or general anesthesia. An angio-CT or an arteriography is necessary to attest the presence for TASC C or D lesion involving the superficial femoral and/or popliteal arteries.
The long femoropopliteal lesion must be pre-dilated during 3 minutes with a balloon of 1mm diameter more than the stent to be implanted.
A control arteriography will be done before the implantation of the stent and at the end of the intervention to assess the success of the procedure.
If needed, endovascular treatment could be realized on the inflow or outflow in the same time.
Patient follow-up :
Patient follow-up is performed at 1, 6, 12 and 24 months. Follow-up will systematically include a clinical evaluation and a duplex scan with the ankle brachial index (ABI).
The x-rays and the quality of life questionnaire will be done at 1, 12 and 24 months.
All clinical surveillance events, complications and re-hospitalizations will be collected.
- Conditions
- Atherosclerosis Obliterans
- Being tested
- Endovascular treatment for PAD during medical care (SuperA stent (Abbott))
- Keywords
- femoropopliteal artery, interwoven nitinol stent, self-expanding-endovascular, TASC C and TASC D, Peripheral Arterial Disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment for PAD during medical care (SuperA stent (Abbott))Device
Also called long femoropopliteal revascularization
Long femoropopliteal stenting with SuperA devices during medical care. The endovascular treatment for PAD will be done during the usual medical treatment of patient. The intervention is not carried out within the framework of the research protocol
| Study group | Role | What they receive |
|---|---|---|
| patients with femoropopliteal lesion | patients with femoropopliteal lesion - Endovascular treatment for PAD during medical care Receives: Device: Endovascular treatment for PAD during medical care (SuperA stent (Abbott)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with improvement of at least one category of Rutherford classification
To evaluate the sustained clinical effectiveness of the SuperA stent (Abbott) at 12-month for TASC C and D atherosclerotic femoropopliteal lesions in patients with symptomatic primary artery disease (PAD) (RUTHERFORD 2 to 6).
Improvement of at least 1 category of Rutherford classification for claudicants.
Healing of a trophic disorder and disappearance of resting pain for patient with critical ischemia
Measured: 12 months
Secondary outcomes (22)
Number of patient with improvement of at least one category of Rutherford classification
clinical effectiveness of the SuperA stent measurement
Measured: 24 months
number of patient presenting a major adverse cardiovascular event
clinical effectiveness of the SuperA stent measurement
Measured: 24 months
number of patient presenting a major adverse limb event
clinical effectiveness of the SuperA stent measurement
Measured: 24 months
limb salvage rate measurement
clinical effectiveness of the SuperA stent measurement
Measured: 24 months
rate of Target Lesion Revascularization (TLR)
Effectiveness of the SuperA stent measurement
Measured: 24 months
rate of Target Extremity Revascularization (TER)
Effectiveness of the SuperA stent measurement
Measured: 24 months
number of patient with sustained permeability without restenosis > 30% in lack of reintervention
hemodynamic effectiveness of the SuperA stent measurement
Measured: 24 months
number of patient with sustained permeability without restenosis > 30% after reintervention
hemodynamic effectiveness of the SuperA stent measurement
Measured: 24 months
variation of the ABI (Ankle systolic pression (mmHg) / brachial systolique pression (mmHg) index) before and after surgery
hemodynamic effectiveness of the SuperA stent measurement
(restenosis, thrombosis) and morphologic criteria (stenting length, stent fracture).
Measured: 24 months
restenosis measurement
hemodynamic effectiveness of the SuperA stent measurement
Measured: 24 months
thrombosis measurement
hemodynamic effectiveness of the SuperA stent measurement
Measured: 24 months
stenting length measurement
morphologic criteria of effectiveness of the SuperA stent measurement
Measured: 24 months
stent fracture measurement
morphologic criteria of effectiveness of the SuperA stent measurement
Measured: 24 months
quality of life in patients treated with the SuperA stent
EuroQol five dimensions questionnaire (EQ5D-3L)
Measured: 1 month
quality of life in patients treated with the SuperA stent
EQ5D-3L questionnaire
Measured: 12 months
quality of life in patients treated with the SuperA stent
EQ5D-3L questionnaire
Measured: 24months
Assessment of vessel calcification rate
For predictive factors of failure
Measured: 24months
Assessment of elongation rate of SuperA
For predictive factors of failure
Measured: 24months
Assessment of stent diameter
For predictive factors of failure
Measured: 24months
Number of patient presenting cardiovascular comorbidity
For predictive factors of failure
Measured: 24months
Number of patient presenting a renal dysfunction (creatinine clearance < 60 mL/min and/or dialysis)
For predictive factors of failure
Measured: 24months
Number of patient treated with anti-platelet therapy
For predictive factors of failure
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis ObliteransStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Yann Goueffic, PU-PH, Principal investigator, yann.goueffic@chu-nantes.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020290
- Sponsor's protocol ID
- RC15_0464
- Acronym
- STELLASUPERA
- Status last verified
- Sep 2019
- First submitted
- 21 Dec 2016
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents
- ClinicalTrials.gov ID
- NCT03020290
- Acronym / sponsor ID
- STELLASUPERA / RC15_0464
- Conditions
- Atherosclerosis Obliterans
- Keywords
- femoropopliteal artery, interwoven nitinol stent, self-expanding-endovascular, TASC C and TASC D, Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Dec 2016
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D).
The primary objective of the study was to evaluate the clinical efficacy at 12 months of the SuperA stent (Abbott) in the treatment of long de novo atherosclerotic lesions TASC C and D in patients with symptomatic peripheral arterial disease. The secondary objectives are to evaluate the clinical effectiveness of the SuperA stent at 24 months, according to clinical, morphological and haemodynamic criteria, the possible influence of calcifications and the quality of life of patients.
The SuperA stent treatment is not specifically provided for by the Protocol but is carried out within the framework of the care. This study is an observationnal study.
Detailed description
Patient will be recruiting during 1 year. Patient will be followed in the study during 2 years. Pre-operative exams are collected. Patients are asked to give their oral authorization to participate in the study by their surgeon.
Patient can be included up to the next day of the intervention.
Endovascular treatment of femoropopliteal lesion with SuperA stents during medical care:
Intervention will be achieved in operative room, under local anesthesia and sedation or general anesthesia. An angio-CT or an arteriography is necessary to attest the presence for TASC C or D lesion involving the superficial femoral and/or popliteal arteries.
The long femoropopliteal lesion must be pre-dilated during 3 minutes with a balloon of 1mm diameter more than the stent to be implanted.
A control arteriography will be done before the implantation of the stent and at the end of the intervention to assess the success of the procedure.
If needed, endovascular treatment could be realized on the inflow or outflow in the same time.
Patient follow-up :
Patient follow-up is performed at 1, 6, 12 and 24 months. Follow-up will systematically include a clinical evaluation and a duplex scan with the ankle brachial index (ABI).
The x-rays and the quality of life questionnaire will be done at 1, 12 and 24 months.
All clinical surveillance events, complications and re-hospitalizations will be collected.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with femoropopliteal lesion | – | Device: Endovascular treatment for PAD during medical care (SuperA stent (Abbott))patients with femoropopliteal lesion - Endovascular treatment for PAD during medical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included in this study are major patients and have lower limb arteriopathy requiring a therapeutic gesture in the femoro-popliteal segment. The inclusion in this study will be proposed to the patients during the consultation of preoperative vascular surgery or during the hospitalization, until the day after their intervention. The number of subjects planned is 50. In the case where the patient has bilateral femoropopliteal lesions, the limbs being treated in separate hospitalizations, both members may be treated with SuperA stents. The two members will then be considered independently of each other. Patients with associated lesions requiring treatment, any artery confused, may be treated at the same operative time if deemed necessary by the surgeon.
Key inclusion criteria (5 listed)
- Age > 18 years,
- Symptomatic PAD, Rutherford 2 to 6
- Atherosclerotic femoropopliteal lesion TASC C or D (on CT scan or arteriography)
- De novo femoropopliteal lesion
- Patient informed of the study and oral authorization collected
Key exclusion criteria (16 listed)
- Under-age patient
- Patient of age, but under legal guardianship or care
- Potentially pregnant women
- Patients do not understand the French language
- Asymptomatic lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular treatment for PAD during medical care (SuperA stent (Abbott))Also: long femoropopliteal revascularizationLong femoropopliteal stenting with SuperA devices during medical care. The endovascular treatment for PAD will be done during the usual medical treatment of patient. The intervention is not carried out within the framework of the research protocol | Device | patients with femoropopliteal lesion |
Primary outcome
Number of patient with improvement of at least one category of Rutherford classification
Time frame: 12 months
To evaluate the sustained clinical effectiveness of the SuperA stent (Abbott) at 12-month for TASC C and D atherosclerotic femoropopliteal lesions in patients with symptomatic primary artery disease (PAD) (RUTHERFORD 2 to 6). Improvement of at least 1 category of Rutherford classification for claudicants. Healing of a trophic disorder and disappearance of resting pain for patient with critical ischemia
22 secondary outcomes
Number of patient with improvement of at least one category of Rutherford classification
Time frame: 24 months
number of patient presenting a major adverse cardiovascular event
Time frame: 24 months
number of patient presenting a major adverse limb event
Time frame: 24 months
limb salvage rate measurement
Time frame: 24 months
rate of Target Lesion Revascularization (TLR)
Time frame: 24 months
rate of Target Extremity Revascularization (TER)
Time frame: 24 months
number of patient with sustained permeability without restenosis > 30% in lack of reintervention
Time frame: 24 months
number of patient with sustained permeability without restenosis > 30% after reintervention
Time frame: 24 months
variation of the ABI (Ankle systolic pression (mmHg) / brachial systolique pression (mmHg) index) before and after surgery
Time frame: 24 months
restenosis measurement
Time frame: 24 months
thrombosis measurement
Time frame: 24 months
stenting length measurement
Time frame: 24 months
stent fracture measurement
Time frame: 24 months
quality of life in patients treated with the SuperA stent
Time frame: 1 month
quality of life in patients treated with the SuperA stent
Time frame: 12 months
quality of life in patients treated with the SuperA stent
Time frame: 24months
Assessment of vessel calcification rate
Time frame: 24months
Assessment of elongation rate of SuperA
Time frame: 24months
Assessment of stent diameter
Time frame: 24months
Number of patient presenting cardiovascular comorbidity
Time frame: 24months
Number of patient presenting a renal dysfunction (creatinine clearance < 60 mL/min and/or dialysis)
Time frame: 24months
Number of patient treated with anti-platelet therapy
Time frame: 24months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yann Goueffic, PU-PH principal investigator
yann.goueffic@chu-nantes.fr
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis Obliterans, run by Nantes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient with improvement of at least one category of Rutherford classification (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.